Study of Recombinant Interleukin 21 in Combination With Sorafenib for Metastatic Renal Cell Carcinoma

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate whether recombinant IL-21 used in combination with sorafenib is safe for patients with metastatic renal cell carcinoma (RCC).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ZymoGenetics
• Treatments: Niacinamide; Sorafenib

Criteria

Inclusion Criteria:

• Diagnosis of RCC of predominantly clear cell histology

• Either no prior treatment or a maximum of 2 prior treatment regimens for metastatic RCC that included no more than 1 treatment regimen targeting the vascular endothelial growth factor (VEGF) pathway (Phase 1 only)

• At least 1 but no more than 2 prior systemic therapies for metastatic RCC that included no more than 1 therapy targeting the VEGF pathway (Phase 2 only)

• Disease measurable per the Response Evaluation Criteria in Solid Tumors (RECIST) (Phase 2 only)

Exclusion Criteria:

• Presence of acute infection or other significant systemic illness

• Central nervous system involvement by malignancy

• History of other cancer within 5 years

• Previously received rIL-21 or sorafenib